Ethical considerations in studying drug safety--the Institute of Medicine report

N Engl J Med. 2012 Sep 6;367(10):959-64. doi: 10.1056/NEJMhle1207160. Epub 2012 Aug 22.

Authors

Michelle M Mello¹, Steven N Goodman, Ruth R Faden

Affiliation

¹ Department of Health Policy and Management, Harvard School of Public Health, Boston, USA.

PMID: 22913661
DOI: 10.1056/NEJMhle1207160

No abstract available

MeSH terms

Bioethical Issues*
Drug Approval
Drug-Related Side Effects and Adverse Reactions*
Humans
Informed Consent*
National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division
Product Surveillance, Postmarketing* / standards
United States
United States Food and Drug Administration / ethics*